Device Changes, FDA Changes, and the 510(k) Conference
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
Areas Covered in the Session:
- U.S. FDA device clearance / approval
- FDA's and EU's emphasis
- Product changes and filing a new 510(k) - who's responsible
- Tracking and evaluating changes - the "tipping point"
Who Will Benefit:
- Senior management, project leaders, internal / external consultants
- Regulatory affairs
- Quality systems personnel / QAE
- R&D and engineering staff
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
http://www.compliance4all.com/
Event Link : http://www.compliance4all.com/control/w_product/~product_id=501053LIVE?channel=mailer&camp=Webinar&AdGroup=govevents_Jan_2017_SEO
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Speaker and Presenter Information
John E Lincoln
Consultant, Medical device and Regulatory Affairs
John E Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.
Relevant Government Agencies
FDA Changes
Event Type
Webcast
This event has no exhibitor/sponsor opportunities
When
Wed, Jan 25, 2017, 10:00am - 11:00am
PT
Website
Click here to visit event website
Organizer
NetZealous - Compliance4All
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@Compliance4all
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